Sr. Principal Engineer, Process System Owner - Filling Systems

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Job Function:
Supply Chain Engineering

Job Sub Function:
Process Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Wilson, North Carolina, United States of America

Job Description:

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As part of the Global Process Engineering team, the Sr. Principal Engineer, Process System Owner - Filling Systems, is the technical expert in aseptic filling. They will be accountable for overall E2E process engineering leadership in the design and execution of implementing new filling line systems (both vial and syringe) into a new cGMP drug product manufacturing plant. They will be responsible for leveraging their scientific, technical, and business expertise to develop the system equipment, solve sophisticated technical issues, optimize the process, lead commissioning and qualification activities and line start-up and ensure full compliance to regulatory standards.

Key Responsibilities:

• Development and delivery of filling line system specifications and drawings (user requirements, data sheets, technical specifications, P&IDs, PFDs)
• Assess vendor competency and capabilities, review and discuss bid documents, and be held accountable for project development and execution, including performance of the process systems
• Lead the detailed design and development of the filling line system equipment (E-Beam, isolator, filling line) collaborating with a diverse multi-functional team including strategic equipment vendors
• Lead the design of the filling lines facility area
• Lead equipment FAT, SAT, C&Q, and start-up
• Technical issue resolution on the system during C&Q testing and the readiness of the system to start C&Q activities
• Helping to identify and expedite key activities across multiple business functions (Manufacturing, Facilities, MSAT, Quality, Procurement, E&PS (Engineering & Property Services), and EHS
• Ensure alignment across evolving business needs and require strong partner management and leadership skills to collaborate across these multiple business partners
• Maintain a solid understanding of industry trends and benchmarking against internal/external practices
• Apply data-driven insights and market intelligence to advise future decision making, stay informed on industry and regulatory trends, and adapt strategies accordingly to achieve excellent portfolio performance
• Ensure compliance with policies, procedures, government regulations, and customer specifications

Qualifications

Education:

• Minimum of a Bachelor's Degree in engineering required (Mechanical Engineering preferred), MS or MBA preferred.

Experience and Skills:

Required:

• A minimum of 10 years experience in process engineering or capital project execution of filling line systems in a biotherapeutics cGMP environment
• Track record of developing and maintaining strong partnerships with key stakeholders
• Ability to lead and motivate multicultural teams and remote customers
• Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize, and execute project plans as filling system SME
• Excellent problem-solving skills when handling potential conflicts
• Understanding sophisticated technical/regulatory issues impacting facility/equipment design

Solid understanding of the following:

• cGMP's for aseptic manufacturing of multiple regulatory bodies (EU, FDA), including fluency in the understanding of new EU Annex 1 guidelines and its impact on facility/equipment design
• EHS requirements, with particular focus on EHS by design and construction safety
• Start-up processes and Commissioning & Qualification of filling line system equipment
• Principles for engineering design for drug products in the Biotherapeutic industry
• Construction & Procurement process
• Project Controls processes
• Project scheduling
• Strong technical process engineering knowledge and experience and has a great passion for solving highly complex technical problems
• Strong problem solving, communication, and decision-making skills to drive impact in a fast-paced evolving business landscape
• Ability to drive process engineering innovation for equipment and facilities ensuring technical knowledge is maintained and expanded throughout the team

Preferred:

• Consistent track record on leading capital projects for filling systems in the range of $50 - $100 MM$
• Strong process engineering expertise in conceptual design through C&Q (commissioning & qualification) to ensure efficient operational readiness within a biotherapeutic drug product environment in filling systems
• Experience in green or brown field GMP manufacturing facility start-up

Other:

• This position will be located in Wilson, North Carolina, and will require full time on-site support. However, the design of the facility will occur at an Engineering firm with frequent travel (> 75%) required until the project shifts to the plant site of Wilson, NC.

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Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:
Agile Decision Making, Coaching, Consulting, Corrective and Preventive Action (CAPA), Crisis Management, Cross-Functional Collaboration, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Tactical Planning, Technical Credibility, Technical Research